Roteas (edoxaban)
- Region
- 🇪🇺 EU
- Active substance
- edoxaban
- Company
- Berlin-Chemie AG
- Status
- Authorised
- Therapeutic area
- Stroke; Venous Thromboembolism
- CHMP opinion
- Wed 22 Feb 2017
- EU approval
- Wed 19 Apr 2017
- Application
- EMEA/H/C/004339
- ATC
- B01AF03
- Official record
- www.ema.europa.eu
Indication
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lixiana Authorised · Daiichi Sankyo Europe GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.